Deviation Investigation Team Manager

What you will do:

• Lead and develop the Deviation Investigation Team, ensuring Technical Investigators are trained, coached, and competent in investigation methodologies, root cause analysis, technical writing, and GMP compliance.
• Oversee and drive the timely closure of manufacturing and technical-service deviations, ensuring investigations are completed to the required quality, scientific, and compliance standards while supporting batch disposition timelines.
• Apply a risk-based approach to quality events, proactively identifying, managing, reporting, and escalating risks and issues that could impact product quality, compliance, or customer delivery.
• Partner with cross-functional stakeholders, including Manufacturing, MSAT, QA, QC, QP, and Project Management, to ensure effective collaboration, accountability, and resolution of deviation investigations.
• Lead customer communications relating to deviation events, providing clear updates, facilitating investigation meetings, and ensuring customer expectations are effectively managed.
• Drive continuous improvement initiatives and deviation-related projects, enhancing investigation quality, right-first-time performance, compliance, and on-time closure metrics.
• Monitor, analyse, and report investigation performance metrics, providing oversight of team effectiveness, supporting strategic decision-making, and ensuring inspection and audit readiness.
• What we are looking for:
• A BSc in a relevant scientific or engineering discipline, or equivalent experience, providing a strong foundation in biopharmaceutical development or manufacturing.
• Experience within the biotechnology, pharmaceutical, or GMP manufacturing industry, with a strong understanding of quality systems, compliance requirements, and operational challenges.
• Proven expertise in deviation investigations, root cause analysis (RCA), and risk management tools such as FMEA, with the ability to identify effective corrective and preventive actions.
• Excellent communication and stakeholder management skills, capable of building strong relationships and influencing internal teams, customers, auditors, and senior business stakeholders.
• Strong technical writing capability, with experience authoring and reviewing deviations, investigations, technical reports, and other GMP quality documentation.
• Experience supporting regulatory inspections and customer audits, confidently presenting investigation outcomes and acting as a subject matter expert for quality and compliance activities.
• Demonstrated ability to lead improvement initiatives and solve complex problems, using data-driven decision making to enhance investigation quality, compliance, and operational performance.

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